MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-11-11 for COBAS INTEGRA 400 PLUS 03245233001 manufactured by Roche Diagnostics.
[18083823]
It was unknown if the initial reporter sent report to the fda. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[18128062]
The customer received a questionable acetaminophen result on their integra 400 plus analyzer. Sample testing was performed on serum samples in aliquot tubes. The patient's initial acetaminophen result was 23. 5 umol/l and was reported outside the laboratory. Later that morning, the customer tested a new blood draw and the result was 276. 6 umol/l accompanied by a data flag. The repeat result was 279. 0 umol/l accompanied by a data flag later that afternoon, the customer tested a third blood draw and the result was 95. 2 umol/l. The repeat result was 93. 7 umol/l. As the patient was admitted to the hospital for an acetaminophen overdose, the customer retested the first sample. The initial sample's first repeat result was 931. 8 umol/l accompanied by a data flag. The second repeat result was 932. 3 umol/l accompanied by a data flag. There were no adverse events. The acetaminophen lot number and expiration date was not provided.
Patient Sequence No: 1, Text Type: D, B5
[18200875]
A specific root cause could not be determined. The raw data of the initial sample measurement shows that no sample was pipetted; however a specific cause for the pipetting issue could not be identified. A root cause with the application or reagent itself could be excluded. No adverse event was reported. The patient had been admitted to hospital due to an overdose of acetaminophen and the physician continued the treatment regardless of the result.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-06129 |
| MDR Report Key | 2333659 |
| Report Source | 01,05,06 |
| Date Received | 2011-11-11 |
| Date of Report | 2012-03-09 |
| Date of Event | 2011-10-25 |
| Date Mfgr Received | 2011-10-26 |
| Date Added to Maude | 2011-11-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA 400 PLUS |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LDP |
| Date Received | 2011-11-11 |
| Model Number | NA |
| Catalog Number | 03245233001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-11 |